Cancer de la prostate métastatique: prise en charge précoce

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1 Cancer de la prostate métastatique: prise en charge précoce Stéphane Oudard, MD, PhD Georges Pompidou Hospital, Oncology Department, Paris, France

2 SAGB.CAB c 3/02/2016 Les questions actuelles dans le cancer de la prostate métastatique? A t-on fait des progrès en terme de survie globale depuis 30 ans? Définissons nous mieux le volume tumoral en phase métastatique : faible vs fort volume tumoral? Est ce que la chimiothérapie peut-être proposer plus tôt? A t-on des facteurs prédictifs de réponse aux TT?

3 Where to place docetaxel in metastatic setting and how to optimize it s therapeutic index?

4 Testosterone (ng/dl) Systemic treatment with Androgen Ablation Systemic treatment with Androgen Ablation Charles HUGGINS Charles HUGGINS The effect of castration on advanced carcinoma of the prostate gland. Arch Surg, 1941 days

5 Survie globale (%) Survival curve with previous clinical trials in hormone-naive setting Overall survival of metastatic patients treated with hormonal therapies in an hormone-naive situation At risk Death Median (months) Inclusion Date S S S Mois depuis l inclusion 168 C. Tangen et al. J Urol Oct ; 188(4) :

6 Survival with Newly Diagnosed Metastatic Prostate Cancer in the Docetaxel Era : Data from 917 Patients in the Control Arm of the STAMPEDE Trial Prognostic Factors of PFS and OS: - Younger age (< 65 yrs), - Presence of bone metastases with or without soft tissue metastases, - Gleason Score > 8, - And WHO PS > 1. James ND T et al, Eur Urol 2014, in press

7 Activity of Docetaxel in metastatic Castration Resistant PC Tannock I, et al, NEJM, 2004 Fossa D, et al, Eur Urol, 2007 Petrylak D, et al, NEJM, 2004 Oudard S, et al, J Clin Oncol, 2005

8 Co-existence of AR-positive and AR-negative tumour cells in the same patient AR-negative cells AR-positive cells Beltran H. Cancer discovery 2011; 1:

9 SAGB.CAB c 3/02/2016 Combination of drug regimen in HSPC: CT & ADT Results of the tree trials addressing the question on early CT in HSPC: CHAARTED trial GETUG AFU 15 trial STAMPEDE trial

10 CHAARTED Trial: Hormone-naïve metastatic patients STRATIFICATION: Extent of Mets: High vs Low Age: 70 vs < 70 yo ECOG PS: 0-1 vs 2 CAB> 30 days: Yes vs No SRE Prevention: Yes vs No Prior Adjuvant ADT: 12 vs >12 mos 1:1 ARM A: ADT + Docetaxel 75 mg/m 2 every 21 days for maximum 6 cycles ARM B: ADT (androgen deprivation therapy alone) Evaluate every 3 weeks while receiving docetaxel and at week 24 then every 12 weeks Evaluate every 12 weeks Follow for time to progression and overall survival Chemotherapy at investigator s discretion at progression ADT allowed up to 120 days prior to randomization. Intermittent ADT dosing was not allowed Standard dexamethasone premedication but NO daily Prednisone Sweeney C et al. N Engl J Med august 2015

11 SAGB.CAB c 3/02/2016 Key eligibility criteria High volume metastatic disease: visceral metastases and/or 4 or more bone metastases (with at least 1 beyond pelvis and vertebral column) At study initiation, only patients with high volume disease were included: Study amendment to allow patients with low volume to be enrolled, with stratification on disease volume Sweeney C et al. N Engl J Med august 2015

12 High volume disease is prognostic of outcome in hormone-sensitive disease Study Regimen Patient number Definition of disease spread OS low vs high volume disease SWOG: S Orchidectomy +/- flutamide SWOG: S Leuprolide +/- flutamide 1387 Appendicular skeletal, visceral met or both 603 Absence of mets in ribs, long bones, skill, soft tissues except lymph nodes 51 vs 27 months 39 vs 26 months SWOG 3 Intermittent vs continuous ADT 3040 Ribs, long bones or visceral mets Continuous tx 6.9 vs 4.4 yrs MD Anderson 4 ADT +/- KAVE or more bone mets or visceral mets 7.8 vs 3.75 yrs 1 Eisenberger et al. N Eng J Med 1988;339: ; 2 Crawford et al. N Eng J Med 1989;321:419-21; 3 Hussain et al. N Eng J Med 2013;368: ; 4 Millikan et al. J Clin Oncol 2008;26: Stéphane Oudard discussant at ESMO Annual Meeting 2014

13 CHAARTED trial: Overall Survival for global patients population month OS benefit whatever the volume of the disease ADT, androgen deprivation therapy; D, docetaxel Sweeney C et al. N Engl J Med august 2015

14 CHAARTED: OS by Extent of Metastatic Disease at Start of ADT High volume Low volume ADT alone Median 32.2 mths Hazard Ratio: 0.60 (95% CI ) P= ADT + DOC Median 49.2 mths ADT alone Not reached ADT + DOC Not reached Hazard Ratio: 0.63 (95% CI ) P= In patients with high volume metastatic disease, there is a 17 month improvement in median OS We projected 33 months in ADT alone arm with collaboration of SWOG9346 team Sweeney C et al. N Engl J Med august 2015

15 CHAARTED: Chemotherapy + ADT benefited all subgroups of patients with high volume disease Favors ADT + D Favors ADT alone Sweeney C et al. N Engl J Med august 2015

16 Limitations (Questions) of CHAARTED trial Mixed population composed of localized prostate cancer evolving toward a metastatic disease (27%) vs de novo M1 patients (73%) Are these patients comparable? Local treatment, failure PSA GETUG 15 : 28% CHAARTED : 27% STAMPEDE : 5% Metastasis hormono-naive and prgression Metastasis De Novo GETUG 15 : 72% CHAARTED : 73% STAMPEDE : 95% Stéphane Oudard discussant at ESMO Annual Meeting 2014

17 GETUG-15: Metastatic hormone-naïve patients Study Design Metastatic Prostate cancer n=385 1:1 Docetaxel: 75 mg/m 2 q3w (up to 9 cycles) + ADT ADT alone n=192 n=193 Stratification factor: Prior systemic treatment Glass risk groups Primary endpoint: Overall survival (OS) ADT: orchiectomy, or LHRH agonists alone or with non-steroidal anti-androgens Gravis G et al. Lancet Oncol 2013; 14:

18 GETUG-15: clinical PFS and Overall Survival Clinical PFS OS ADT + D: 58.9 mths ADT + D: 23.5 mths ADT: 54.2 mths ADT: 15.4 mths Gravis G et al. Lancet Oncol 2013; 14:

19 GETUG-15: Glass classification chosen Classification: localisation of bone mets, type of mets, Gleason score, ECOG PS and age Glass T et al, J Urol 2003, Vol. 169,

20 Most discriminatory variables in univariate analysis: ALP, pain intensity, Hb, LDH, & bone metastases. ALP: strongest prognostic factor in discriminating patients with good or poor prognosis. mos in pts with normal and abnormal ALP: 69.1 and 33.6 mo / 5-yr survival estimates: 62.1% and 23.2%. HR (ALP): 3.11 and 3.13 in the learning and validation sets. Learning set Validation set ALP: N vs an Kaplan Meier OS curves for the unpruned tree in (A) the learning set and (B) the validation set. Group 1: normal alkaline phosphatase (ALP), Gleason <8, and pain score < 25; group 2: normal ALP, Gleason < 8, and pain score >25; group 3: normal ALP, Gleason > 9; group 4: abnormal ALP, Gleason score > 8; group 5: abnormal ALP, Gleason < 7. Gravis G et al, Eur Urol 2014, online

21 STAMPEDE trial design Patients eligible for STAMPEDE (PI: Nick James) NEWLY DIAGNOSED M1 PATIENTS RANDOMISATION ALL OTHER PATIENTS RANDOMISATION A ADT A ADT (+ RT if N0 M0) B Arm A +zoledronic acid B Arm A + zoledronic acid Closed for inclusion in late 2012 C Arm A + docetaxel C Arm A + docetaxel E Arm A + ZA + docetaxel E Arm A + ZA + docetaxel G Arm A + abiraterone G Arm A + abiraterone H Arm A + RT to prostrate And more to go enabling to include > 5500pts!!! James N et al, ASCO 2015, Abstract #5001

22 STAMPEDE Trial Docetaxel w/wo zoledronic acid for hormone-naive prostate cancer: first overall survival results from STAMPEDE ADT ADT + DOC ADT +ZA ADT+DOC+ZA Median OS 67 months 77 months No difference 78 months HR 0.76 (95% CI 0.63, 0.91; p = 0.003) 0.93 (95% CI 0.79, 1.11; p = 0.4) 0.81 (95% CI 0.68, 0.97; p = 0.020) Grade % 50% 32% 52% N = 2962 patients Median follow-up: 42 months Median PSA: 65 ng/ml Significant survival benefit for ADT + DOC but not for ADT + ZA James N et al, ASCO 2015, Abstract #5001

23 Docetaxel: Failure-free Survival (Stampede Trial) SOC 750 FFS events SOC+Doc 371 FFS events HR (95%CI) 0.62 (0.54, 0.70) P-value < * Non-PH p-value Median FFS (95% CI) SOC 21m (18, 24m) SOC+Doc 37m (33, 42m) Restricted mean FFS time SOC 35.3m SOC+Doc 44.4m Diff (95%CI) 9.1m (6.3, 11.9m) *exact p-value James N et al, ASCO 2015, Abstract #5001

24 Docetaxel: Overall Survival (STAMPEDE Trial) SOC 405 deaths SOC+Doc 165 deaths HR (95%CI) 0.76 (0.63, 0.91) P-value Non-PH p-value 0.51 Median OS (95% CI) SOC 67m (60, 91m) SOC+Doc 77m (70, NR) Restricted mean OS time SOC 58.8m SOC+Doc 63.4m Diff (95%CI) 4.6m (1.8, 7.3m) Nicholas James N et al, oral comm, ASCO 2015 James N et al, ASCO 2015, Abstract #5001

25 M1 docetaxel: Systematic review and metaanalysis Results based on 2993 men / 1254 deaths Trial name CHAARTED GETUG15 STAMPEDE (SOC +/- Doc) STAMPEDE (SOC+ZA +/- Doc) Overall HR=0.77 (0.68, 0.87) p< Favours SOC + docetaxel Heterogeneity: 2 =4.80, df=3, p=0.187, I 2 = 37.5% Favours SOC 10% absolute improvement in survival (from 40% to 50%) at 4 years C Vale et al. ECC 2015 (abstract 20LBA)

26 ADT plus docetaxel is recommended as first-line treatment of metastatic, hormone-naïve disease in men fit enough for chemotherapy [1, A] Parker C et al. Annals Oncol 2015; Suppl 5:v69-v77

27 Taxanes in hormone-sensitive prostate cancer Clinical status Study N Treatment Endpoint Status Neoadjuvant NCT Neoadjuvant NCT Neoadjuvant NCT Adjuvant NCT Adjuvant NCT Adjuvant NCT Rising PSA high risk NCT Risking PSA high risk NCT CALGB RPP +/- Doc/ADT PFS 83% accrued Dana-Farber 350 DOC/ADT x3 XRT+ADT OS Accrued PEACE XRT+ADT +/- Cab cpfs Started RTOG XRT+ADT +/- Cab OS Completed ADPRO 459 RRP+/- Doc x6 PFS PSA Completed AdRAD 378 XRT+ADT +/- Doc PFS Completed French trial 252 ADT +/- Doc x6 PFS Completed TAX ADT +/- Doc x10 PFS Completed Stéphane Oudard discussant at ESMO Annual Meeting 2014

28 Management of metastatic prostate cancer is rapidly evolving 2015 treatment options Non metastatic Metastatic hormone naive mcrpc asymptomatic (failed ADT + docetaxel) mcrpc mildly symptomatic mcrpc symptomatic Docetaxel* + ADT Cabazitaxel Abiraterone Enzalutamide Sipuleucel-T *for chemofit patients Radium 223 Supportive care (eg denosumab/biphosphonates ESMO guidelines 2015

29 Conclusions Patients with hormone-naïve metastatic disease: ADT + docetaxel largely increased OS compared with ADT alone in two different trials (CHAARTED and STAMPEDE) and should be Considered for routine practice in suitable men with newly-diagnosed metastatic disease Quality of life is awaited and STAMPEDE trial publication is awaited Optimal treatment for low volume disease is not yet known (follow-up): ADT + CT or Nx HT? Local treatment of the primary should be considered more often in the multimodality setting No predicitive factors are known so far Future perspectives: Improved distinction between low-volume and high volume skeletal disease Identification of the disease s biology by liquid & tissue biopsies

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